Re: the American Heart Association Scientific Statement entitled “Pediatric Therapeutic Cardiac Catheterization” (Circulation. 1998;97:609–625). In the section on the buttoned device for closure of atrial septal defects (p. 611), the authors stated that “The device has not undergone a clinical IDE trial nor has it been approved by the FDA.” This is in fact incorrect. E.B. Sideris, MD, wrote to the authors: “The buttoned device underwent the phase I FDA approved trial under an IDE between 1991–1992. Acute and follow-up results of this trial have been published (Lloyd TR, Rao PS, Beekman III RH, Mendelson AM, Sideris EB. Atrial septal defect occlusion with the buttoned device [a multi-institutional trial] Amer J Cardiol. 1994;73:286–291.) Three USA centers participated in the clinical trial. A phase II FDA approved trial is currently on the way in 5 centers and is approaching completion. It is possible that the buttoned device will be the first ASD occluding device to be ready for pre-market approval. Numerous hours were spent for the development of the method and the paperwork required for the 35 supplements sent to FDA so far; thousands of dollars have been spent in FDA-ordered testing.” The authors apologize for this error. The electronic version of the paper, available on the AHA website (http://www.americanheart.org/Scientific/statements/1998/029802.html) has been corrected, and subsequent reprints will also reflect the change.
- Copyright © 1998 by American Heart Association